- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04521218
Thrust Joint Manipulation and Reverse SNAGS (Sustained Natural Apophyseal Glides) in Cervicogenic Headache
Comparison of Thrust Joint Manipulation and Reverse SNAGS (Sustained Natural Apophyseal Glides) of Upper Cervical Spine in Cervicogenic Headache
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In 1983 the term "cervicogenic headache" was introduced in an article in the medical literature. The diagnostic criteria of cervicogenic headache was revised in 1998. The international headache society classified the types of headaches based on their source and characteristics. Studies showed that out of 47% of the patients suffering from headache. 38% are tension-type ; 10% are migraine ; 3% chronic headache and 2.5 to 4.1 % are cervicogenic headaches.The prevalence of cervicogenic headache (CH) after the whiplash is as high as fifty-three percent.Literature revealed that due to varying use of diagnostic measures it is difficult to find out the true prevalence of cervicogenic headache but it ranges from minimum 0.7% to maximum 13.8% in population.
The headache which is originated from the cervical spine and pain is referred to the head region is termed as Cervicogenic headache.So, the source of pain is a cervical region located near the base of the skull, pain is referred from the neck region which travels towards the occulo-frontal and temporal areas of the head.Cervicogenic headache is four times more prevalent in females than males. Females suffer more from cervicogenic head due to hormonal imbalances and poor posture. Poor posture includes the forward headache posture which affects the normal biomechanics of the cervical spine and increases the stress on the neck region.
The possible cause of cervicogenic headache is said to be the supply of the upper three cervical nerves and its various distributions.Upper three cervical nerves innervate the atlantoaxial joint, atlantooccipital joint, facet joint (C2-C3), suboccipital, paravertebral. upper posterior neck musculature, upper cervical ligaments, spinal dura mater, the vertebral artery, intervertebral disc (C2-C3), trapezius, and sternocleidomastoid muscles. Any of these structures is the possible source of pain and it should be diagnosed first. According to the criteria of the International headache society (IHS) impairment in the function of upper cervical muscles is the source of cervicogenic headache.Patients suffering from cervicogenic headaches show a decrease in their quality of life and also compromised physical abilities as compared to other types of headaches.
A multifaced approach is required to treat the patients suffering from cervicogenic headaches. Most commonly pharmacological, non-pharmacological, physical therapy, anesthetic blockade, and sometimes surgical approach is used. A successful intervention requires a multidisciplinary team of physicians including a pain specialist, anesthesiologist, physical therapist, a psychologist to provide a suitable treatment. For the long-lasting effect of the nerve blocks and neurolytic procedures, physical therapy and rehabilitation are required.
Different physical therapy treatments including thrust joint manipulation, mobilizations, exercise program, postural education, or modification used as an effective intervention of cervicogenic headache. A combination of these treatments is used to subside the symptoms of CH.
Literature review:
A systematic and evidence-based search of relevant literature was performed by utilizing PubMed and Google Scholar as search engines and the key words used were sustained natural apophyseal glides, thrust joint manipulation, mulligan, and reverse sustained natural apophyseal glides. The purpose of the literature review is to find out the pre-existing literature regarding the Reverse SNAGS and TJM interventions for cervicogenic headache.
According to a systematic review and meta-analysis conducted in 2019 on cervicogenic headache to find out the effectiveness of mobilization and manipulation compared to other conservative interventions in reducing pain and disability. So, it was concluded that both mobilization and manipulation are effective in cervicogenic headache but there were few limitations in the study that only nine studies were included and more quality research are required. Further research is required to observe the long-term effect and other interventions for clinical effectiveness.
An overview of systematic reviews was conducted in 2019 on the physical therapy interventions for cervicogenic headache. Results from the reviews stated that manipulation, mobilization, and other conservative interventions were effective in decreasing the frequency of pain and disability in patients suffering from cervicogenic headaches.
According to a randomized control trial conducted in 2019 on cervicogenic headache. The purpose of the study was to determine the effectiveness of headache sustained natural apophyseal glide (SNAG) and SNAG rotation separately as well as in combination in patients suffering from cervicogenic headache to reduce the headache and improve activity limitation. The results of the study showed that group that received both SNAG and SNAG rotation technique is effective in reducing cervicogenic headache.
A randomized control trail in 2018 on cervicogenic headaches. The purpose of the study was to compare the effectiveness of SNAG and reverse SNAG on patients suffering from cervicogenic headache. Results showed that headache SNAG was more effective than reverse SNAG in treating patients suffering from cervicogenic headache. The major limitation of the study was limited sample size and lack of quantitative equipment for measuring the change.
In recent studies, results reported that Sustained Natural Apophyseal Glides and Thrust Joint Manipulation (TJM) were effective in the management of Cervicogenic Headache. However, they did not report if manipulation resulted in superior outcomes compared to mobilization for the management of this population, or secondly no literature was found regarding the reverse SNAGs as an intervention for cervicogenic headache. The purpose of this study is to compare the effects of reverse SNAG and TJM in patients with cervicogenic headache regarding the improvement of headache, pain, pain pressure threshold, and cervical range of motion
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Fedral
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Islamabad, Fedral, Pakistan, 44000
- Max health Rehabilitation Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Headache frequency of at least 1 per week for a minimum of 3 months
- Secondary Headache (cervical spine dysfunction)
International Classification of headache Disorder:
- Pain localized in the neck and occiput, which can spread to other areas in the head, such as forehead, orbital region, temples, vertex, or ears, usually unilateral.
- Pain is precipitated or aggravated by specific neck movements or sustained postures.
At least one of the following:
- Resistance to or limitation of passive neck movements
- Changes in neck muscle contour, texture, tone, or response to active and passive stretching and contraction
- Abnormal tenderness of neck musculature
Exclusion Criteria:
- Other types of headache
- Trigger points of upper cervical muscles
- Congenital conditions of cervical spine
- Cervical Disc herniation
- Fracture
- Cervical Artery disease
- Red flags of Thrust Joint Manipulation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thrust joint Manipulation
Thrust joint Manipulation, heat application, Strengthening exercise and home plan
|
Experimental group included TJM, Cervical hot pack, strengthening exercises and home plan; 3 sessions of manipulation per week and total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. Pain intensity, pain pressure threshold, ROM, and disability. These exercises included. Cervical Flexion, Extension Rotation, lateral flexion and back strengthening exercises. These all exercises were performed 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week. Home plan exercises includes Craniocervical Flexion, Craniocervical Extension, Rotation Exercise, Lateral Flexion Exercise, Chin Tuck in and Shoulder blade exercise were advised to perform 3 x 10 Repetition with 10 - 30 sec hold. |
Active Comparator: Reverse Sustained Natural apophyseal glides
Reverse Sustained Natural apophyseal glides (SNAG), heat application, Strengthening exercise and home plan.
|
Control group included Moist Hot Pack (Cervical contour- 8.25 x 10 x 2) for 10 Mins, Reverse SNAGS (10 Repetitions holding for 10 sec in each glide with a rest time of 30 seconds in between), Strengthening exercise and home plan. 3 sessions of mobilization per week and total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. Pain intensity, pain pressure threshold, ROM, and disability. These exercises included. Cervical Flexion, Extension Rotation, lateral flexion and back strengthening exercises. These all exercises were performed 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week. Home plan exercises includes Craniocervical Flexion, Craniocervical Extension, Rotation Exercise, Lateral Flexion Exercise, Chin Tuck in and Shoulder blade exercise were advised to perform 3 x 10 Repetition with 10 - 30 sec hold |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: 12th Day
|
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10.
where 0 indicate no pain and 10 indicate severe pain.
|
12th Day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Pain Threshold (PPT)
Time Frame: 12th Day
|
Changes from Baseline Pressure Pain Threshold (PPT) were taken with the help of algometer.
|
12th Day
|
Headache Disability Index
Time Frame: 12th Day
|
Scoring instructions: Yes = 4 points, Sometimes = 2, No = 0. Using this system, a total score of 10-28 is considered to indicate mild disability; 30-48 is moderate disability; 50-68 is severe disability; 72 or more is complete disability
|
12th Day
|
Range of Motion(ROM) Cervical (Flexion)
Time Frame: 12th Day
|
Changes from the baseline ROM range of motion of cervical spine flexion was taken with the help of inclinometer
|
12th Day
|
ROM Cervical (Extension)
Time Frame: 12th Day
|
Changes from the baseline ROM range of motion of cervical spine Extension was taken with the help of inclinometer
|
12th Day
|
ROM Cervical (Side Bend)
Time Frame: 12th Day
|
Changes from the baseline ROM range of motion of cervical spine Side bending was taken with the help of inclinometer
|
12th Day
|
ROM Cervical Rotation
Time Frame: 12th Day
|
Changes from the baseline ROM range of motion of cervical spine rotation was taken with the help of inclinometer
|
12th Day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Saira Waqqar, PP-DPT, MHPE, Riphah International University
Publications and helpful links
General Publications
- Bogduk N, Govind J. Cervicogenic headache: an assessment of the evidence on clinical diagnosis, invasive tests, and treatment. Lancet Neurol. 2009 Oct;8(10):959-68. doi: 10.1016/S1474-4422(09)70209-1.
- Mohamed AA, Shendy WS, Semary M, Mourad HS, Battecha KH, Soliman ES, Sayed SHE, Mohamed GI. Combined use of cervical headache snag and cervical snag half rotation techniques in the treatment of cervicogenic headache. J Phys Ther Sci. 2019 Apr;31(4):376-381. doi: 10.1589/jpts.31.376. Epub 2019 Apr 1.
- Umar M, Naeem A, Badshah M, Zaidi S. A randomized control trial to review the effectiveness of cervical mobilization combined with stretching exercises in cervicogenic headache. J Public Health Biolo Sci. 2012;1(1):09-13.
- Lord SM, Barnsley L, Wallis BJ, Bogduk N. Third occipital nerve headache: a prevalence study. J Neurol Neurosurg Psychiatry. 1994 Oct;57(10):1187-90. doi: 10.1136/jnnp.57.10.1187.
- Sjaastad O, Saunte C, Hovdahl H, Breivik H, Gronbaek E. "Cervicogenic" headache. An hypothesis. Cephalalgia. 1983 Dec;3(4):249-56. doi: 10.1046/j.1468-2982.1983.0304249.x. No abstract available.
- Sjaastad O, Fredriksen TA, Pfaffenrath V. Cervicogenic headache: diagnostic criteria. The Cervicogenic Headache International Study Group. Headache. 1998 Jun;38(6):442-5. doi: 10.1046/j.1526-4610.1998.3806442.x. No abstract available.
- Haldeman S, Dagenais S. Cervicogenic headaches: a critical review. Spine J. 2001 Jan-Feb;1(1):31-46. doi: 10.1016/s1529-9430(01)00024-9.
- Fleming R, Forsythe S, Cook C. Influential variables associated with outcomes in patients with cervicogenic headache. J Man Manip Ther. 2007;15(3):155-64. doi: 10.1179/106698107790819846.
- Evers S. Comparison of cervicogenic headache with migraine. Cephalalgia. 2008 Jul;28 Suppl 1:16-7. doi: 10.1111/j.1468-2982.2008.01609.x. No abstract available.
- van Suijlekom JA, Weber WE, van Kleef M. Cervicogenic headache: techniques of diagnostic nerve blocks. Clin Exp Rheumatol. 2000 Mar-Apr;18(2 Suppl 19):S39-44.
- Biondi DM. Cervicogenic headache: diagnostic evaluation and treatment strategies. Curr Pain Headache Rep. 2001 Aug;5(4):361-8. doi: 10.1007/s11916-001-0026-x.
- Bogduk N. The neck and headaches. Neurol Clin. 2004 Feb;22(1):151-71, vii. doi: 10.1016/S0733-8619(03)00100-2.
- Jull G, Barrett C, Magee R, Ho P. Further clinical clarification of the muscle dysfunction in cervical headache. Cephalalgia. 1999 Apr;19(3):179-85. doi: 10.1046/j.1468-2982.1999.1903179.x.
- Jamil M, Janjua U. Comparison of cervicogenic headache between housewives and working women. Rawal Medical Journal. 2020 Jan;45(1):77-9.
- Umar M, Badshah M, Maryam M, Naeem A, Rehman L, Ahmed M. Prevalence Of Different Types Of Headache In Medical Students Of Rawalpindi & Islamabad. International Journal of Rehabilitation Sciences (IJRS). 2018 Mar 15;4(01):15-9.
- Coelho M, Ela N, Garvin A, Cox C, Sloan W, Palaima M, et al. The effectiveness of manipulation and mobilization on pain and disability in individuals with cervicogenic and tension-type headaches: a systematic review and meta-analysis. Physical Therapy Reviews. 2019;24(1-2):29-43
- Rani M, Kulandaivelan S, Bansal A, Pawalia A. Physical therapy intervention for cervicogenic headache: an overview of systematic reviews. European Journal of Physiotherapy. 2019:1-7
- Rasul HNU, Dustagir A, Malik AN. Role of Mobilization to Improve Cervicogenic Headache
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00694 Amna Arshad
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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